DABIGATRAN ETEXILATE STADA 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dabigatran Etexilate Stada 150 mg Hard Capsules EFG

Readtheentirepackageleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontainsimportantinformationforyou.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contentsofthepackageleaflet

1. What is Dabigatran Etexilate Stada and what is it used for
2. What you need to know before you take Dabigatran Etexilate Stada
3. How to take Dabigatran Etexilate Stada
4. Possible side effects
5. Storage of Dabigatran Etexilate Stada
6. Package contents and further information

1. What is Dabigatran Etexilate Stada and what is it used for

This medicine contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabigatran etexilate is used in adults to:

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treat blood clots in the veins of your legs and lungs and to prevent them from forming again in the veins of your legs and lungs.

Dabigatran etexilate is used in children to:

• treat blood clots and prevent them from forming again.

2. What you need to know before you take Dabigatran Etexilate Stada

DonottakeDabigatranEtexilateStada

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently bleeding.
• if you have any disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be inherited, of unknown cause or caused by other medicines.
• if you are taking medicines to prevent blood clots (e.g. warfarin, rivaroxaban, apixaban or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being administered heparin through this catheter to keep it open or while your normal heart rhythm is being restored through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or you have a life-threatening liver disease.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral ciclosporin, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat irregular heartbeat.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have been implanted with an artificial heart valve that requires permanent anticoagulant treatment.

Warningsandprecautions

Consult your doctor before starting to take dabigatran etexilate. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you are to undergo surgery.

Tell your doctor if you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• • if you have recently had bleeding.
  • if you have had surgical tissue removal (biopsy) in the last month.
  • if you have had a severe injury (e.g. a bone fracture, a head injury or any injury that required surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have problems with stomach acid reflux into the esophagus.
  • if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Dabigatran Etexilate Stada" below.
  • if you are using anti-inflammatory medicines such as diclofenac, ibuprofen or piroxicam.
  • if you have a heart infection (bacterial endocarditis).
  • if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored urine).
  • if you are over 75 years old.
  • if you are an adult patient and weigh 50 kg or less.
  • only if used in children: if the child has a brain infection or around the brain.

• If you have had a heart attack or if you have been diagnosed with diseases that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

BeespeciallycarefulwithDabigatranEtexilateStada

• If you need to undergo surgery:

In this case, dabigatran etexilate should be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.

• If surgery requires the placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia or for pain relief):
• • It is very important that you take dabigatran etexilate before and after surgery exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the end of anesthesia, as this situation requires urgent attention.

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.

• If you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), tell your doctor to decide if it may be necessary to modify the treatment.

OthermedicinesandDabigatranEtexilateStada

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, you must tell your doctor before taking dabigatran etexilate if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole), except if only applied to the skin
• Medicines used in the treatment of irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil)

If you are using medicines that contain verapamil, your doctor may instruct you to use a reduced dose of dabigatran etexilate. See section 3.

• Medicines for the prevention of organ rejection after a transplant (e.g. tacrolimus, ciclosporin)
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g. ritonavir)
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancyandbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The effects of dabigatran etexilate on pregnancy and the fetus are not known. You should not take this medicine if you are pregnant unless your doctor advises you to. If you are of childbearing potential, you should avoid becoming pregnant during treatment with dabigatran etexilate.

Breast-feeding is not recommended during treatment with dabigatran etexilate.

Driving and using machines

Dabigatran etexilate has no known effects on the ability to drive and use machines.

Dabigatran Etexilate Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Dabigatran Etexilate Stada

Dabigatran etexilate capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other pharmaceutical forms suitable for the treatment of children under 8 years.

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor again.

TakeDabigatranEtexilateStadaasrecommendedforthefollowingsituations:

Prevention of cerebral or systemic vascular obstruction by blood clot formation after irregular heartbeat and treatment of blood clots in the veins of your legs and lungs, including prevention of blood clots in the veins of your legs and lungs from forming again

The recommended dose is 300 mg administered as one 150 mg capsule twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered as one 110 mg capsule twice a day.

If you are using medicines that contain verapamil, you should be instructed to use a reduced dose of dabigatran etexilate of 220 mg taken as one 110 mg capsule twice a day, as your risk of bleeding may be increased.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg administered as one 110 mg capsule twice a day.

You can continue taking this medicine if it is necessary to restore your normal heart rhythm through a procedure called cardioversion or through a procedure called catheter ablation for atrial fibrillation. Take dabigatran etexilate as instructed by your doctor.

If you have been implanted with a medical device (vascular endoprosthesis) in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis, you may receive treatment with dabigatran etexilate once your doctor has decided that normal blood coagulation control has been achieved. Take dabigatran etexilate as instructed by your doctor.

Treatment of blood clots and prevention of blood clots from forming again in children

Dabigatran etexilate should be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The administration interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue using all other medicines unless your doctor tells you to stop using one.

Table 1 shows the single and total daily doses of dabigatran etexilate in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosing table for dabigatran etexilate capsules

Doses that require combinations of more than one capsule:

300 mg: two 150 mg capsules or

four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or

one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or

two 75 mg capsules

HowtotakeDabigatranEtexilateStada

Dabigatran etexilate can be taken with or without food. The capsule should be swallowed whole with a glass of water, to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Instructionsforthebottle

• Press and turn to open.
• After removing the capsule, put the cap back on the bottle and close the bottle immediately after taking your dose.

ChanginganticoagulanttreatmentwithDabigatranEtexilateStada

Do not change your anticoagulant treatment without specific instructions from your doctor.

IfyoutakemoreDabigatranEtexilateStada

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

IfyouforgettotakeDabigatranEtexilateStada

A forgotten dose can be taken up to 6 hours before the next dose.

A forgotten dose should be omitted if the time before the next dose is less than 6 hours. Do not take a double dose to make up for forgotten doses.

IfyoustoptakingDabigatranEtexilateStada

Take dabigatran etexilate exactly as prescribed. Do not stop your treatment with this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience indigestion after taking dabigatran etexilate.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Dabigatran etexilate acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which are the most severe adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

• If you experience any episode of bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

• Inform your doctor immediately if you experience a severe allergic reaction that causes difficulty breathing or dizziness.

Other Adverse Effects

Possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of cerebral or systemic vascular obstruction due to blood clot formation developed after abnormal heart rhythm

Frequent(may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling like vomiting

Uncommon(may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

Rare(may affect up to 1 in 1,000 people):

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of red blood cells
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Frequency Not Known(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical trial, the rate of heart attacks with dabigatran etexilate was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs

Frequent(may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Indigestion

Uncommon(may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur in a joint or in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling like vomiting
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Abnormalities in liver function tests
• Increased liver enzymes

Rare(may affect up to 1 in 1,000 people):

• Bleeding may occur at the site of a surgical incision, or at the site of an injection, or at the site of a catheter in a vein or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Difficulty swallowing

Frequency Not Known(frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of red blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran etexilate was higher than with warfarin. The overall incidence was low. No imbalance was observed in the rate of heart attacks in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots in children

Frequent(may affect up to 1 in 10 people):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling like vomiting
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Uncommon(may affect up to 1 in 100 people):

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood spots
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

Frequency Not Known(frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including esophageal ulcer)
• Abnormalities in liver function tests

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: http://www.aemps.gob.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabigatran Etexilate Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the carton, blister, or bottle after "EXP". The expiration date is the last day of the month indicated.

Blister: Store below 30°C.

Bottle: Store below 30°C. Store in the original package to protect it from moisture. Once opened, the medicine must be used within 60 days.

Follow these instructions to remove the capsules from the bottle:

• The cap is opened by pressing and turning.
• After removing the capsule, the cap should be put back on the bottle immediately and the bottle should be closed tightly.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is dabigatran. Each hard capsule contains 150 mg of dabigatran etexilate (in the form of mesilate).
• The other ingredients are tartaric acid (E334), hypromellose, talc, hydroxypropylcellulose (E463), croscarmellose sodium, and magnesium stearate (E470b).

The capsule shell contains titanium dioxide (E171) and hypromellose.

Black printing ink: shellac (E904), propylene glycol (E1520), iron oxide black (E172), and potassium hydroxide (E525).

Appearance of the Product and Package Contents

Dabigatran Etexilate Stada 150 mg are hard capsules with an opaque white cap and an opaque white body, size "0" (21.50 ± 0.40 mm), containing a mixture of white to pale yellow pellets and a pale yellow granulate. They are printed with black ink with the letters "MD" on the cap and the inscription "150" on the body.

This medicine is available in packages containing OPA/Al/desiccant PE-Al/PE blisters of 10, 30, 60, or 180 hard capsules.

This medicine is also available in 120 ml and 150 ml polypropylene bottles with a child-resistant closure and desiccant, containing 60 hard capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park, Paola, PLA 3000,

Malta

or

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814NE Breda,

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/